Effects of Upper Airway Muscle Training on Obstructive Sleep Apnea Severity

Stanford University

Status: Withdrawn

Conditions: Sleep Apnea

Treatments: Device: Exercise equipment (a musical instrument that is based on the Medical Didgeridoo)

Study type: Interventional

Funder types: Other

Identifiers

NCT04053153

IRB-46406

Details and patient eligibility

About

The purpose of this study is to evaluate the effect of Asate Silent Sleep Training on obstructive sleep apnea (OSA) severity in patients with mild to moderate OSA. The Asate Silent Sleep Training is a muscle strengthening program that uses exercise equipment (a musical instrument that is based on the didgeridoo). The equipment is connected to an application, which provides instruction on how to perform the strengthening exercises, measures the sound produced by the musical instrument, which enables the app to provide feedback on whether the individual should blow less or more and also tracks adherence to the strengthening program.

Sex: All

Ages: 21 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 21 to 50
• Diagnosed by a physician with mild to moderate OSA, based upon interpretation of data recorded on a take home sleep study
• Body mass index < 30 kg/m2
• Mild to moderate OSA, AHI of 5-30

Exclusion criteria

1. Apnea hypopnea index on overnight sleep study > 30 per hour
2. Currently practices didgeridoo
3. Consumes more than 2 alcoholic beverages per day
4. History of chronic lung disease (e.g., COPD, asthma)
5. Oral maxillofacial issue or craniofacial musculoskeletal conditions
6. Any treatment for OSA (current or past)
7. Mobile device use frequency < once per week
8. Homelessness
9. No reliable transportation to assessment sessions
10. Planned social/family/employment obligations that would limit participant from engaging in Asate Silent Sleep training during the intervention period
11. Significant upper extremity weakness/paralysis or pain limiting ability to hold the Medical Didgeridoo
12. Uncorrected low vision or blindness
13. Deafness
14. No Internet connection/Chrome browser/mobile devices with iOS and Android
15. No USB port in computer
16. Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

Use of musical instrument

Experimental group

Treatment:

Device: Exercise equipment (a musical instrument that is based on the Medical Didgeridoo)

Use of sham musical instrument

Sham Comparator group

Treatment:

Device: Exercise equipment (a musical instrument that is based on the Medical Didgeridoo)